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EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome (EEGInspiration)

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ClinicalTrials.gov Identifier: NCT02751216
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

Brief Summary:
This study is an interventional, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome patients with back and leg pain.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Other: EEG recording + pain protocol Not Applicable

Detailed Description:

Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication.

Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: spinal cord stimulation Other: EEG recording + pain protocol



Primary Outcome Measures :
  1. Functional connectivity [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    EEG recordings to measure functional connectivity in the brain


Secondary Outcome Measures :
  1. Functioning of the descending inhibitory pathway [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water

  2. Visual Analogue Scale (VAS) pain diary [ Time Frame: Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion). ]
  3. Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics). [ Time Frame: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation). ]
    This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality

  4. Pain Catastrophizing [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    Pain catastrophizing is assess be using the 'pain catastrophizing scale'.

  5. Subjective sleep quality [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years old.
  2. Subject is able and willing to comply with the follow-up schedule and protocol
  3. Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain.
  4. Cognitive and language functioning enabling coherent communication between the examiner and the subject;
  5. Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
  6. Stable neurologic function in the past 30 days
  7. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
  8. Subject is able to provide written informed consent
  9. Subject speaks Dutch or French.

Exclusion Criteria:

  1. Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
  2. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  3. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
  4. Subject is unable to operate the device or has no relative available.
  5. Subjects with indwelling devices that may pose an increased risk of infection
  6. Subjects currently has an active infection
  7. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
  8. Subject has participated in another clinical investigation within 30 days
  9. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  10. Subject has been diagnosed with cancer in the past 2 years
  11. Life expectancy < 6 months
  12. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
  13. Existing extreme fear for entering MRI
  14. General contraindication for MRI (pacemaker, etc…)
  15. Age male/female patient <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751216


Locations
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Belgium
UZ Brussel
Brussels, Vlaams Brabant, Belgium, 1090
Sponsors and Collaborators
Moens Maarten
Investigators
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Principal Investigator: Maarten Moens, Prof. dr. Universitair Ziekenhuis Brussel

Publications:
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Responsible Party: Moens Maarten, Prof. dr., Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02751216     History of Changes
Other Study ID Numbers: EEGInspiration1
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

Keywords provided by Moens Maarten, Universitair Ziekenhuis Brussel:
high frequency / high density spinal cord stimulation
EEG
conditioned pain modulation

Additional relevant MeSH terms:
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Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms